AVID Medical Recalls Halyard EP PACK Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits, Model Number VANW018-06. The recall involves 12 eaches of the product, identified by GTIN 10809160401941 and Lot Number 1598601. The product was distributed nationwide in the United States.
The recall is being conducted because sponge forceps and towel clamps associated with the kits may have small loose metal flakes that could detach from the components. These metal flakes may enter a patient's surgical site undetected, potentially causing local reactions or possible foreign body reactions.
Healthcare facilities and consumers who have purchased these specific kits should stop using them and contact AVID Medical, Inc. for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Halyard EP PACK - Medical convenience kits Model Number: VANW018-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 10809160401941 Lot Number: 1598601
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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